Isomark NewsletterJune 2017

2017 has proven to be a productive year for the Isomark team. In this newsletter we give an update on the ongoing infection study, introduce an athletic performance study, and discuss the most recent developments made to our device.

In addition, this coming fall we are planning to launch our infection detection regulatory trial with the goal of FDA clearance in 2018.

Sincerely,
Joe Kremer, CEO

Infection Study Update

How things are progressing.

At the start of our human clinical studies we began with a proof-of-concept study. Follow this link to those study results. Since then we expanded the study, following patients for a longer period of time and gathering additional data on how our biomarker tracks the infection process from early onset to progression to a patient’s response to treatment.

We have collected the most recent study results and our internal team is working with our study investigators on a publication that will be released and presented at this fall’s AAST (American Association for the Surgery of Trauma) annual meeting in Baltimore. Once available publicly, we will be sure to share the exciting results with you.

In the meantime we are working on a third pre-submission to the FDA and are targeting to launch our regulatory trial this fall, which will focus on gathering the data needed for a 510k submission for our infection detection biomarker.

Athletic Performance Study

Studying how Isomark can help with peak performance.

Isomark’s technology is based on detecting metabolic change and macronutrient use. By knowing an individual’s energy utilization (carbohydrates, proteins or fats) and how metabolism changes during a workout, it is possible to enhance fitness goals. Whether that is to manage weight or improve performance, a bit of knowledge can go a long way.

Last year Isomark launched a study with elite collegiate athletes. The results were compelling enough we presented the findings at Experimental Biology 2017 in Chicago, view the poster. During the study, Isomark was able to identify athletes who were training with a negative energy balance, meaning the group being studied was losing weight at a time they were hoping to build muscle mass. The study was featured in the Wisconsin State Journal.

This summer the study is entering an expanded phase focused on how this information can help individuals achieve their performance goals. Our plan is to be on the market with the energy balance technology as early as this coming fall. As always, we will share results with you once available.

Device Development

An integrated prototype comes to life.

This past fall Isomark compiled feedback from study site personnel, our own techs and a focus group to create our first clinical device prototype. This version of the CanaryTMdevice is movable, boasts a five-port auto-sampler (which enables a more efficient analysis and improved integration with clinical workflow), auto-calibration, battery operation, and a simple touchscreen user interface.

We are working on some refinements including the expansion of the auto-sampler to 12 and 24 ports, adding a bar code reader to obtain patient ID, integration with a hospital’s electronic medical record (EMR) system, and size reduction. Plans are underway for further cost and size reduction, with a goal of ultimately designing a handheld version that is inexpensive enough to enable market expansion all the way through to personal home health and fitness.

For Investigational Use Only. The performance characteristics of this product have not been established.

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